Context:The Treatment for Adolescents With Depression Study evaluates the effectiveness of fluoxetine hydrochloride therapy, cognitive behavior therapy (CBT), and their combination in adolescents with major depressive disorder.Objective: To report effectiveness outcomes across 36 weeks of randomized treatment.Design and Setting: Randomized, controlled trial conducted in 13 academic and community sites in the United States. Cognitive behavior and combination therapies were not masked, whereas administration of placebo and fluoxetine was double-blind through 12 weeks, after which treatments were unblinded. Patients assigned to placebo were treated openly after week 12, and the placebo group is not included in these analyses by design.Participants: Three hundred twenty-seven patients aged 12 to 17 years with a primary DSM-IV diagnosis of major depressive disorder.Interventions: All treatments were administered per protocol. Main Outcome Measures:The primary dependent measures rated blind to treatment status by an independent evaluator were the Children's Depression Rating ScaleRevised total score and the response rate, defined as a Clinical Global Impressions-Improvement score of much or very much improved.Results: Intention-to-treat analyses on the Children's Depression Rating Scale-Revised identified a significant time ϫ treatment interaction (P Ͻ .001). Rates of response were 73% for combination therapy, 62% for fluoxetine therapy, and 48% for CBT at week 12; 85% for combination therapy, 69% for fluoxetine therapy, and 65% for CBT at week 18; and 86% for combination therapy, 81% for fluoxetine therapy, and 81% for CBT at week 36. Suicidal ideation decreased with treatment, but less so with fluoxetine therapy than with combination therapy or CBT. Suicidal events were more common in patients receiving fluoxetine therapy (14.7%) than combination therapy (8.4%) or CBT (6.3%). Conclusions:In adolescents with moderate to severe depression, treatment with fluoxetine alone or in combination with CBT accelerates the response. Adding CBT to medication enhances the safety of medication. Taking benefits and harms into account, combined treatment appears superior to either monotherapy as a treatment for major depression in adolescents.

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To our knowledge, this is the first randomized controlled trial of atomoxetine in children as young as 5 years. Atomoxetine generally was well tolerated and reduced core ADHD symptoms in the children on the basis of parent and teacher reports. Reductions in the ADHD-IV Rating Scale scores, however, did not necessarily translate to overall clinical and functional improvement, as demonstrated on the Clinical Global Impression-Severity Scale and the Clinical Global Impression-Improvement Scale. Despite benefits, the children in the atomoxetine group remained, on average, significantly impaired at the end of the study.

Atomoxetine was generally effective for reducing core ADHD symptoms in the 5 and 6 year olds in this open-label study.

The purpose of this study was to examine in a controlled trial the effects of atomoxetine on the management of attention deficit-hyperactivity disorder (ADHD) symptoms and functional impairments at school and at home. Participants were 153 children (age 8 to 12 years) diagnosed with attention-deficit hyperactivity disorder who were randomized to double-blind treatment with either atomoxetine (n = 101) or placebo (n = 52). Findings revealed significant improvements both for parent and teacher ratings of behavior for children receiving atomoxetine therapy. Children also were reported to evidence a trend toward better response to active medication than to placebo for health-related quality of life as rated by parents. No significant effects were revealed for the teacher ratings of academic productivity. Data were interpreted to provide support for the efficacy of atomoxetine on the symptoms associated with ADHD. The effects of atomoxetine on other functional outcomes including academic performance and health-related outcomes are of interest, albeit less compelling for this particular investigation, than for the effects on overt symptom display.